Clinical trial · Interventional
Intravenous Iron for Correction of Anaemia After Colorectal Surgery
The Impact of Treatment of Anaemia With Intravenous Iron on Haematological Values for Patients After Colorectal Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery. The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia, Iron-Deficiency | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Surgery | — | UNRESOLVED | — |
| Intravenous Drug Usage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iron isomaltoside | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment
- description
- 1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).
- interventionNames
- Drug: Iron isomaltoside
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).
- interventionNames
- Drug: Saline
Primary outcomes (1)
- measure
- Changes in haemoglobin level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * elective colorectal cancer surgery * preoperative haemoglobin 90-120 g/l * preoperative plasma ferritin \<100 mkg/l Exclusion Criteria: * laparoscopic colorectal surgery * body mass \<50kg * history of overdosage of iron products * family history of haemochromatosis, thalassaemia, * non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies) * under treatment with erythropoietin, intravenous iron or blood transfusion in the last 12 weeks * allergy to iron carboxymaltose or its supplements * body temperature \> 37.5 °C or under antibiotic use * chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times over normal upper limit * patients ill with grave bronchial asthma * patients with manifestation of allergy
References
Publications (8)
- BACKGROUNDShander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013. PMID 15050887
- BACKGROUNDEdna TH, Karlsen V, Jullumstro E, Lydersen S. Prevalence of anaemia at diagnosis of colorectal cancer: assessment of associated risk factors. Hepatogastroenterology. 2012 May;59(115):713-6. doi: 10.5754/hge11479. PMID 22469713
- BACKGROUNDWard DG, Roberts K, Brookes MJ, Joy H, Martin A, Ismail T, Spychal R, Iqbal T, Tselepis C. Increased hepcidin expression in colorectal carcinogenesis. World J Gastroenterol. 2008 Mar 7;14(9):1339-45. doi: 10.3748/wjg.14.1339. PMID 18322945
- BACKGROUNDGanz T. Hepcidin and iron regulation, 10 years later. Blood. 2011 Apr 28;117(17):4425-33. doi: 10.1182/blood-2011-01-258467. Epub 2011 Feb 23. PMID 21346250
- BACKGROUNDLeichtle SW, Mouawad NJ, Lampman R, Singal B, Cleary RK. Does preoperative anemia adversely affect colon and rectal surgery outcomes? J Am Coll Surg. 2011 Feb;212(2):187-94. doi: 10.1016/j.jamcollsurg.2010.09.013. PMID 21276532
- BACKGROUNDCladellas M, Bruguera J, Comin J, Vila J, de Jaime E, Marti J, Gomez M. Is pre-operative anaemia a risk marker for in-hospital mortality and morbidity after valve replacement? Eur Heart J. 2006 May;27(9):1093-9. doi: 10.1093/eurheartj/ehi830. Epub 2006 Mar 14. PMID 16537556
- BACKGROUNDHogan M, Klein AA, Richards T. The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. doi: 10.1093/ejcts/ezu200. Epub 2014 May 13. PMID 24824650
- Elhenawy AM, Meyer SR, Bagshaw SM, MacArthur RG, Carroll LJ. Role of preoperative intravenous iron therapy to correct anemia before major surgery: study protocol for systematic review and meta-analysis. Syst Rev. 2015 Mar 15;4:29. doi: 10.1186/s13643-015-0016-4.